Blinded By Its Cow-Urine Craze, the Government Isn't Fostering Good Research Practices

One 'finding' suggests cancer and MDR-TB patients consuming a cow-urine distillate along with their medication can reduce the dosage of their medication and still reap positive results. This is dangerous.

In a rush to push out 'research' that reaffirms the beliefs of some of its ministers, including related to cow urine, the government has been undercutting good practices. Credit: paulspace/Flickr, CC BY 2.0

On July 3, researchers at Junagadh Agricultural University (JAU), Gujarat, claimed to have elucidated the ability of cow urine to kill cancer cells. Their study does not exhibit the use of a proper methodology nor does it appear to have passed peer review (in a non-predatory journal). According to one unqualified news report, the researchers have also said that following potentially successful clinical trials in “a rat”, they will begin manufacturing oral pills for human consumption. More than causing alarm, such pronouncements have turned distressing.

The Government of India, led by Shripad Naik, the minister of state for AYUSH, has been promoting traditional medicines with wilful disregard for the inability of researchers it has sponsored to show how, or if at all, the medicines actually work, threatening the lives of millions of people suffering from cancer in the country (by trying to feed them a cure that likely won’t work) and by diverting perceptibly finite resources away from proven treatments that could use the support.

Much the AYUSH ministry’s thrust has been through efforts to promote the use of cow urine as a form of medication. According to a PTI report on November 25, Naik said in a statement that “the Council of Scientific and Industrial Research (CSIR) through its constituent laboratories has conducted research studies in collaboration with Go-Vigyan Anusandhan Kendra, Nagpur, on cow urine distillate for its antioxidant and bio-enhancing properties on anti-infective and anti-cancer agents and nutrients”. This raises many concerns, and though some may seem downright funny, they do present some awful consequences. Here are six.

1. No transparency – Research into phytotherapy (the study of extracts of natural origin) and ayurveda, apart from other forms of traditional and non-allopathic medicine, needs to be encouraged. This is because a robust defence or dismissal of various traditional fomulations’ efficacies is needed to differentiate between legitimate and quack medicines peddled among the people, especially in rural areas. However, the Ministry of AYUSH, despite its ostensible support for these forms of medicine, has made little effort to publish research it funds in peer-reviewed journals, put up its findings in the public domain or submit to public peer-review/data-validation. It hasn’t mandated any healthy practices either, leading to an abundance of ‘studies’ with little or no merit.

2. Patents instead of papers – The Ministry of AYUSH’s announcements in the media are often accompanied by claims that so-so patents have been received (as well as, for some reason, backing from NASA). While patents signify uniqueness, they don’t mean the patented object is useful to the human body. Such a thing has to be proven separately. Moreover, some claims don’t hold up when followed up (like so many things in the post-truth era). In the case of the purportedly anti-diabetic drug BGR-34, developed by CSIR and commercialised by the Ministry of AYUSH earlier this year, no patents were found to have been granted for the formulation even though officials had claimed that they had been. If such utterances are kept up, they will only make future claims – howsoever legitimate – seem less reliable.

3. Loss of resources – In October 2015, the Government of India halved the CSIRs’ budget and asked the various centres to make up the remaining half by themselves through product realisations. They were also asked to redirect their focus towards social-sector technologies (including research on cow urine) and submit reports of their ‘progress’ every month. This move effectively amounted to a funding cut of about Rs 2,000 crore. And together with the first two issues, the cut indicates what has really changed since mid-2015: Robust and reliable research in the country has lost access to many of the CSIR’s 38 centres, their infrastructure and their research; organisations have lost access to Rs 2,000 crore in research funds; and the research the CSIR has devoted itself to since has not been producing consistently reliable results.

4. Research protocols – Despite being a priority ministry* for the government, the Ministry of AYUSH has displayed an apparent disdain for the established methods of scientific investigation. (In the Union Budget announced in March 2016, the Ministry of Ayush received a 16.6% hike – slightly below the 17% hike received by the Department of Science & Technology but well above the 12% hike received by the Department of Biotechnology.) In the case of BGR-34, officials claimed phase III clinical trials had been conducted with 48 patients at the Agarwal Hospital OPD in New Delhi. However, according to Prashant Reddy, a Delhi-based lawyer, the Drugs and Cosmetics Act requires phase III trials for allopathic medications to be conducted with at least 500 people in multiple centres. So, the researchers’ claim that their tests abided by allopathic standards was simply not true.

In another example, researchers from the JAU announced in July 2016 that they had found 3-10 mg of gold in cow urine. However, they couldn’t explain how it got there nor were their results subjected to peer-review. In a third case, the Uttarakhand government announced in the same month that it would spend Rs 25 crore to look for the mythical plant sanjeevani on the basis of its unproven pharmacological versatility (although the Ministry of AYUSH hasn’t yet responded to the proposal). In fact, pre-dating all of these claims is a strange promise made by the BJP campaign in 2013, ahead of the Lok Sabha elections the following year. It was to promote ‘ayurgenomics’ – the use of ayurvedic principles to improve genomic studies. Despite the idea having once been backed by an S.S. Bhatnagar Prize-recipient, it was called out for some grave conceptual problems (one is that it is pegged to astrology).

5. An unspecified substance – Naik’s statement (that PTI reported) suggests the existence of a substance distilled out of cow urine that can enhance the activity of anti-bacterial agents. There are at least three US patents associated with this description: 6410059, 6896907 and 7235262. All three identify the substance only as ‘kamadhenu arka’. All of them also contain the following paragraph: “The novelty of the invention lies in the fact revealed through precise experimentation that the enhancement action and its effectiveness is achievable only in the range of concentration which is literally in nano to micro molar levels. And when a higher concentration/dosage is used in the formulation or combinations the activity(ies) do not appear. That should be the reason for non-detection such a valuable potential of cow urine.” (sic)

There are many issues with this description. First: no records of these ‘precise experiments’ could be found. Second: the substance’s prescribed dosage – of “literally in nano to micro molar levels” – is incredibly low, difficult to control and in fact rings bells about homeopathy. Third: The substance’s chemical composition is never specified. Fourth: A description in the patent document reads, “Cow’s urine can be considered as the most effective animal origin substance/secretion with the capacity of general health improvement” – a sign of confirmation bias – “but it does need substantiation through scientific experimentation”. Fifth: Another part of the document reads, “Further the urine distillate from buffalo, camel, deer provides similar activity of bioavailability.” What then is so unique about the cow? One could go on.

6. Perilous prescription – The patents in question also contain two lines that together lead to a dangerous suggestion. The first is that the cow-urine distillate can enhance the activity of anti-cancer and anti-TB agents: “… the cow urine distillate is used as bioavailability facilitator for anticancer therapy directly or in combination with anticancer molecules” and similarly in “TB therapy including multi drug resistant [MDR] tuberculosis in combination with isoniazid and other anti-tubercular agents”. The second is that the use of the distillate to enhance the activity of anti-microbial agents could bring down the dosage of the latter that’s necessary to be effective: “… the selection pressure will be counter-balanced simultaneously reducing the dosage of antibiotics or drugs for minimising the side effects, which has also high commercial importance” (emphasis added). As a result, the patent (of all things!) is suggesting that cancer and MDR-TB patients consuming the distillate along with their medication can reduce the dosage of their medication and still reap positive results. This a perilous thought that could imperil many lives, endanger India’s already painful efforts to combat the rise of drug-resistant TB and also invite accusations of wilful negligence.

§

As The Wire has noted before – as has the mathematician Manjul Bhargava – it is important to not dismiss these alternative medicinal traditions because we have not explored their full potential through any proper methods yet, at least to the extent that we are able to judge them. Moreover, a WHO-backed report in 2000 noted that double-blind tests are infeasible to figure the efficacies of certain forms of traditional medicine (p. 15) and that they must be modified accordingly. Nonetheless, a Current Science review asserted that any experiments will have to exhibit the features of a randomised control trial as well as the use of “perfected clinical methods, structured documentation of evidence and attention to every clinical feature and its comparable interpretation in both ayurveda and allopathy”.

This deference to allopathy is not to suggest that it is a ‘superior’ form of medication. Instead, it is similar to an idea that Niels Bohr came up with, called the correspondence principle (when applied between quantum and classical physics). According to this principle, if a new theory wants to subsume an older theory, and if the older theory had some predictions that were true in a particular area of application, then the new theory must make the same predictions in that area. Similarly, if alternative, traditional modes of medicine are to subsume some well-established allopathic predictions about, say, how a drug ought to behave, then they must be able to make the same predictions. Interrupting this correspondence is going to lead nowhere.